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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K840082
Device Name STERILE INSULIN DISPOS. NEEDLE/SYRINGE
Applicant
LEE MEDICAL INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LEE MEDICAL INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/10/1984
Decision Date 02/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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